• FDA laser regulations are designed to protect consumers.Laser image by Tigerbeat from Fotolia.com
  
  The Food and Drug Administration (FDA) provides specific regulations for the manufacturing and use of laser, or "light emitting," products. Medical lasers have a wide variety of uses, including eye surgery, hair removal, dental treatment, wrinkle care and other medical procedures. Each state also has laws that govern the use of lasers for different medical uses.
  
  

Registration

• Manufacturers of laser products must register the devices with the FDA's director of the Office of Compliance (HFZ-300), Center for Devices and Radiological Health. Information required in the registration form includes the type of products, name, model number, and the name and address of the manufacturer. In addition, the registration must identify the laser medium or its emitted wavelength.
  
  

Laser Classifications

• Currently the FDA has six classes of lasers: I, II, IIa, IIIa, IIIb and IV. The FDA labels Class I lasers as non-hazardous. Class IIa lasers viewed for less than a specific time also receive the non-hazard label. Class II, Class IIIa and Class IIIb may present various levels of hazards to the skin and eyes. Class IV has the highest level of hazards to the skin and eyes.
  
  

Performance Requirements

• The FDA states that all laser products must have a protective housing. The housing helps prevent people from accessing the laser during operation or the possibility of collateral radiation. In addition, the housing will shield individuals from certain radiation limits, especially when access is not required. The regulations also set the emission limits to the lowest class of radiation exposure necessary when an authorized professional uses the laser for its intended purpose.
  
  

Safety Interlocks

• All lasers must have a minimum of one safety interlock for each component of the protective housing that is designed to be removal or displaced when the laser is undergoing maintenance or in use. If the laser does not have an interlocking mechanism, the amount of collateral radiation exposure to an individual must stay within specified emission limits. The regulation calls for multiple safety interlock or a method to prevent removal or displacement of the protective housing if the radiation or laser exposure would exceed certain limits.
  
  

Control Locations

• Laser products, such as those classified as II, IIa, III or IV, must have control mechanisms or operational methods that reduce the chances of individuals being exposed to the laser or any incidental radiation that exceeds the emission limits, as established for Class I products, when operating or manipulating the controls.
  
  

Viewing Optics

• In all classification of laser products, view ports, display screens and other viewing optics operating as a component of the laser must limit the levels of the actual laser or any secondary radiation accessible to the human eye during the laser's operation or when undergoing maintenance.
  
  

Labels

• The FDA requires all laser products to have warning labels with specific language depending the classification for the product. For example, a product classified as "Class II" must have the following wording: "LASER RADIATION--DO NOT STARE INTO BEAM"; and "CLASS II LASER PRODUCT." The FDA provides guidelines for the type of warning label or the language used on the labels.